Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionAs a
Validation Specialist (known internally as a Data Validation Analyst III), you will lead validation activities for regulated computer systems supporting clinical research. You will partner with cross-functional teams to ensure software applications and digital products meet business needs, regulatory requirements, data integrity expectations, and quality standards throughout the system development lifecycle (SDLC).
You will independently support new system implementations, enhancements, upgrades, integrations, migrations, and ongoing lifecycle activities while applying risk-based validation and Computer Software Assurance (CSA) principles.
A Day in the Life- Lead computerized system validation (CSV) activities for regulated applications throughout the SDLC.
- Develop, review, and approve validation deliverables, including validation plans, risk assessments, test strategies/scripts, traceability matrices, deviations, and validation summary reports.
- Partner with Quality Assurance, IT, Business Analysts, system owners, vendors, and project teams to ensure systems meet business, quality, and regulatory requirements.
- Review requirements, specifications, configurations, vendor documentation, and change controls to ensure they are clear, testable, traceable, and validation ready.
- Define and oversee risk-based testing strategies and ensure validation evidence is complete, accurate, traceable, and inspection-ready.
- Assess system changes and determine appropriate validation scope based on risk, intended use, and regulatory requirements.
- Investigate validation deviations, test failures, and system-related quality issues, including assessment of compliance and data integrity impact.
- Support internal, sponsor, and regulatory audits and inspections as a validation subject matter expert.
- Provide technical guidance and peer review to validation and project team members.
- Contribute to continuous improvement of validation procedures, templates, standards, and governance practices.
This is a home-based role for qualified candidates in the US. Band 6. Applications accepted through 9/8/26.Keys to SuccessQualifications- Bachelor's degree in computer science, Information Systems, Life Sciences, Engineering, Quality, or a related discipline
- Experience
- 5+ years of progressive experience in computerized system validation, computer software assurance, software quality, or validation within a regulated environment.
- Demonstrated experience independently leading complex validation activities and providing technical direction to cross-functional teams.
- Experience supporting GxP-regulated systems, preferably within pharmaceutical, biotechnology, CRO, medical device, laboratory, or healthcare environments.
- Experience working within Agile, Waterfall, or hybrid SDLC methodologies.
- Experience with risk assessments, change control, deviation management, requirements traceability, testing, and maintenance of validated systems.
Preferred QualificationsExperience with:
- Enterprise applications, SaaS/cloud solutions, COTS software, integrations, or data migrations preferred.
- Jira, Azure DevOps, HP ALM, electronic validation lifecycle management systems, or similar validation/testing tools.
- Supporting clinical trial systems such as CTMS, eTMF, EDC, Safety, LIMS, ERP, laboratory, and other GxP-regulated systems.
- Participating as a validation subject matter expert in regulatory inspections, customer audits, or sponsor audits.
- Supplier assessments and leveraging vendor documentation within a risk-based validation strategy.
- Supporting system integrations, interfaces, data migrations, or complex application environments.
- Familiarity with Computer Software Assurance (CSA) concepts and modern risk-based assurance approaches.
- Developing or improving validation procedures, templates, standards, or governance practices.
Knowledge, Skills & Abilities- Strong knowledge of CSV principles and computerized system lifecycle management.
- Strong knowledge of FDA 21 CFR Part 11, GAMP 5, GxP, ALCOA+, data integrity, and risk-based validation methodologies.
- Familiarity with CSA principles and contemporary risk-based assurance approaches.
- Strong analytical, problem-solving, documentation, and technical writing skills.
- Ability to critically review validation and technical documentation and identify compliance, quality, and data integrity risks.
- Strong communication and stakeholder management skills with the ability to influence technical and non-technical teams.
- Ability to manage multiple complex projects and priorities with limited supervision.
- Ability to provide technical leadership, guidance, peer review, and coaching.
- Proficiency with Microsoft Office; experience with Jira, Azure DevOps, HP ALM, or similar validation/testing tools preferred.
- Experience with clinical/GxP systems such as CTMS, eTMF, EDC, Safety, LIMS, ERP, or laboratory systems preferred.
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require as-needed travel (0-20%).
Location: Remote US. Relocation assistance is NOT provided.
The annual salary range estimated for this position in North Carolina is $80,000- $115,000 USD. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
